LR 5200 LASER FILM RECORDER
FDA 510(k) clearance K964414 · decided 1997-01-27
Clearance details
- K-number
- K964414
- Device name
- LR 5200 LASER FILM RECORDER
- Applicant
- Bayer Corp., Agfa Div.
- Decision
- Substantially Equivalent
- Date received
- 1996-11-05
- Decision date
- 1997-01-27
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- LMC
- Device class
- 2
- Regulation number
- 892.2040
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Ridgefield Park, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SCOPIX LR 5200P Laser Imagers, Type 8394/600, serial numbers between 4000 and 5266. recall (Z-0207-04) | AGFA Corp. | 2003-12-11 |